FDA establishes link between NSF Disease and Gadolinium MRI contrast agent

FDA forced to release cautionary information about the correlation between gadolinium-based contrast dyes and NSF.

In June 2006, the Food and Drug Administration first notified healthcare professionals and the public about the risk of NSF following exposure to gadolinium.

The agency was prompted to do so after receiving reports of 25 patients with NSF from the Danish Health Authority. (There are now 1,000 worldwide.) The FDA issued additional information to healthcare professionals and the public in December 2006.

The FDA revealed that it had received reports of patients who developed NSF after being exposed during an MRI to Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance--all products with gadolinium.

The FDA has received reports of patients who died from complications related to NSF. It requested the manufacturers of gandolinium-based products to revise the product labels as soon as possible to include a new boxed warning and new Warnings section that describes the risk of NSF.

If you have developed Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy following an MRI/MRA, you deserve the guidance of a lawyer experienced in such cases. Please complete the form below for a free legal evaluation.

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